The most common drug-related side effect was retrograde ejaculation, or orgasm with reduced semen, which is reversible upon discontinuation of the product. The second most commonly-reported adverse event was dizziness. The incidence of treatment-related dizziness was low and only slightly higher among patients treated with RAPAFLO(R) than placebo-treated patients.
Previously presented data included information that in clinical trials RAPAFLO(R) was administered concomitantly with a single dose of medications for erectile dysfunction in healthy male subjects (N=24) and that there were no reported events of symptomatic orthostatis or dizziness. RAPAFLO(R) demonstrated no meaningful electro cardiac effects during Phase 3 trials and during thorough QTc testing as required for new chemical entities by the FDA.
RAPAFLO(R) was originally developed by Kissei Pharmaceutical Co., Ltd. in Japan, where RAPAFLO(R) is the BPH market leader, and is licensed to Watson for the U.S., Canada and Mexico markets.
Important Safety Information
RAPAFLO(R) is contraindicated in patients with severe renal impairment (CCr <30 mL/min), severe hepatic impairment (Child-Pugh score >/=10), and with use of strong CYP3A4 inhibitors. Postural hypotension with or without symptoms (eg, dizziness) may develop when beginning treatment with RAPAFLO(R). As with all alpha-blockers, there is a potential for syncope. Patients should be warned of the possible occurrences of such events and should avoid situations where injury could result. RAPAFLO(R) should be used with caution in patients with moderate renal impairment. Patients should be assessed to rule out the presence of prostate cancer prior to starting treatment with RAPAFLO(R). Patients planning cataract surgery should inform their ophthalmologist that they are taking RAPAF
|SOURCE Watson Pharmaceuticals, Inc.|
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